Best of DDW 2001. Highlights from the 2001 Digestive Disease Week. May 20-23, 2001, Atlanta, GA.
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Digestive System Diseases↗
Biomedical subjects
N Vakil
Publications and source records attributed to N Vakil.
Dyspepsia, non-ulcer dyspepsia, and Helicobacter pylori.
Since the discovery of Helicobacter pylori and its role in peptic ulcer disease, two strategies for low-cost treatment of uninvestigated dyspepsia have emerged: "test and treat" and "test and scope." The efficacy of these strategies is examined, with a review of several recent studies. Controversy exists as to the usefulness of eradication of H. pylori in the treatment of non-ulcer dyspepsia. Results of four large trials are presented as an illustration of this controversy. Guidelines for the management of dyspepsia and non-ulcer dyspepsia are reviewed.
Dyspepsia↗
Heliobacter Pylori and Non-ulcer Dyspepsia.
There is no definitive therapy for this disorder. Heliobacter pylori eradication therapy is only useful in areas with a high prevalence of H. pylori-related ulcer disease Proton pump inhibitors are effective in short-term treatment for dyspepsia with a predominant symptom of epigastric pain Prokinetic agents may be useful in some patients, particularly those with dysmotility-like dyspepsia, but serious side effects limit their usefulness.
Journal Article↗
Is the stool test out of breath?
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Antigens, Bacterial↗
Recurrent symptoms and gastro-oesophageal reflux disease in patients with duodenal ulcer treated for Helicobacter pylori infection.
BACKGROUND: Eradication of Helicobacter pylori has been shown to prevent relapse of endoscopically detected duodenal ulcers. There is controversy regarding symptom improvement after therapy. Some studies have suggested that a substantial number of patients remain symptomatic after eradication therapy. Other studies suggest that gastro-oesophageal reflux disease (GERD) may develop as a result of H. pylori eradication. AIM: To determine the relationship between symptoms and H. pylori eradication and to determine whether H. pylori eradication results in symptoms or endoscopic findings of GERD. METHODS: Two hundred and forty-two patients with endoscopically documented duodenal ulcer disease and evidence of H. pylori infection by rapid urease testing and histology were studied in four randomized, placebo-controlled, double-blind trials of H. pylori eradication therapy. All patients underwent symptom assessment and endoscopy with biopsy before therapy and 1 and 6 months after completing therapy. The rapid urease test and histology were used to determine H. pylori status. Interviewers were blinded to H. pylori status after eradication and were unaware of the endoscopic findings (interviews were performed prior to repeat endoscopy). RESULTS: The presence of epigastric pain was significantly associated with persistent H. pylori infection 1 month after therapy (odds ratio 2.3, 95% CI: 1.02-5.2; P=0.041), as was nausea (OR 7.1, 95% CI: 0.93-55.6; P=0.029). The presence of epigastric pain was significantly associated with ulcer relapse at 6 months (OR 7.5, 95% CI: 3.6-15.7; P < 0.001) as was nausea (OR 5.1, 95% CI: 1.7-16.0; P=0.002). Heartburn was not associated with eradication of H. pylori or ulcer relapse. New onset reflux symptoms were reported by 17% (17 of 101 patients) at 6 months and were not significantly different in patients with (15%) and without (22%) persistent H. pylori infection (P=0.47). Erosive oesophagitis was present at endoscopy in one of the 17 cases that developed new heartburn. CONCLUSIONS: One month after completion of therapy, the presence of epigastric pain or nausea is associated with persistent infection and these symptoms at 6 months are suggestive of duodenal ulcer relapse. The incidence of GERD is not increased in patients who have eradication of H. pylori.
Adult↗
Technology status evaluation report: computerized endoscopic medical record systems: November 1999.
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Endoscopy, Gastrointestinal↗
Treatment of Helicobacter pylori infection.
Combination antimicrobial therapies for the effective eradication of Helicobacter pylori infection have been identified and are commercially available. Ongoing studies to improve eradication rates are based on modification of currently approved treatments. Management of H. pylori infection now focuses on which patients should be treated and, by extension, which should be tested, because all patients should have a positive test result for H. pylori before starting antimicrobial therapy. Peptic ulcer disease was believed to be caused by acid abnormalities until about two decades ago, when H. pylori was successfully cultured; the clinical records of an early proponent of an infectious cause of peptic ulcer disease were recently discovered. The role of H. pylori infection in gastroesophageal disease and in ulcer disease associated with nonsteroidal anti-inflammatory drugs have become intensely investigated topics. Consensus conferences among pediatric physicians are establishing practice guidelines for H. pylori management in children and adolescents.
Journal Article↗
Admixture with whole blood does not explain false-negative urease tests.
Rapid urease test sensitivity for Helicobacter pylori is reduced in the presence of active upper gastrointestinal bleeding. The aim of this study was to evaluate the in vitro effect of whole blood on rapid urease testing. Urease solution was added to normal saline, and heparinized whole blood both positive and negative for H. pylori antibody. The mixtures were then serially diluted in saline, and/or whole blood and added to three different rapid urease kits. The admixture of urease in H. pylori-seropositive whole blood diluted in either saline or whole blood enhanced performance in both kits fourfold compared with saline alone. No false-negative results were observed in either kit. Seronegative whole blood produced similar results. Undiluted saline or whole blood produced no positive rapid urease tests. Whole blood accelerates the urease reaction in vitro. Neither H. pylori antibody-positive nor -negative whole blood adversely impacted the rapid urease test. False-negative rapid urease test results in upper gastrointestinal bleeding cannot be explained by admixture with whole blood.
Clinical Enzyme Tests↗
Prospective blinded trial of a fecal antigen test for the detection of Helicobacter pylori infection.
OBJECTIVE: We prospectively studied an FDA-approved stool test for the diagnosis of Helicobacter pylori infection based on the detection of antigens shed in stool. METHODS: We studied 108 patients undergoing endoscopy. Stool samples were collected on the day of the endoscopy and read in a blinded manner by a technician who was unaware of the findings of the endoscopy. The results of stool testing were compared to those of the rapid urease test (Pyloritek). RESULTS: There were 51 patients infected with H. pylori by rapid urease testing and 57 who were not. The sensitivity of the stool test was 86% (95% confidence interval: 77-96%), the specificity was 91% (81-97%), with a positive predictive value of 89% (77-96%) and a negative predictive value of 88% (81-97%). The likelihood ratio for a positive test was 10.18 and the likelihood ratio for a negative test was 0.11. CONCLUSIONS: The stool test was sensitive and specific for the detection of H. pylori in a U.S. population.
Antigens, Bacterial↗
The cost-effectiveness of diagnostic testing strategies for Helicobacter pylori.
OBJECTIVE: Several noninvasive methods are now available for diagnosing Helicobacter pylori infection. Because the prevalence of H. pylori infection is variable in patients requiring testing, the optimal testing strategies may vary under different conditions. The aim of this study was to evaluate the cost-effectiveness of competing diagnostic strategies for H. pylori in patients with varying H. pylori prevalence. METHODS: A decision analysis was performed comparing the costs per number of correct diagnoses achieved by alternative sequential testing strategies. Estimates of H. pylori prevalence and test characteristics were derived from a systematic review of the MEDLINE bibliographic database. Cost estimates were derived from the 2000 Medicare Fee Schedule. RESULTS: The enzyme-linked immunosorbent assay (ELISA) test had the lowest cost per correct diagnosis at low (30%), intermediate (60%), and high (90%) prevalence ($90-$95/correct diagnosis), but its diagnostic accuracy was low (80-84%). At low and intermediate prevalence the stool test was more accurate (93%), with an average cost of $126-$127 per correct diagnosis. Additional confirmatory testing of positive or negative tests increased the diagnostic accuracy of the stool test, but had high incremental costs. ELISA testing was preferable when prevalence rates were very high (90%), and using a confirmatory urea breath test for negative ELISA tests increased the diagnostic accuracy to 96%, with modest incremental costs. If the cost of the breath test was <$50 or if the cost of the stool test is >$82, breath testing became preferable to stool testing. If the cost of the stool test fell to <$20, it became preferable to ELISA. Similarly, if the cost of the ELISA serology was >$39 then stool testing became preferable at all prevalence rates. Fingerstick whole blood tests were not cost-effective. CONCLUSIONS: The choice of an initial test for H. pylori detection depends on the prevalence of H. pylori infection and the value placed on increased diagnostic accuracy. Although ELISA results in the lowest cost-effectiveness ratios, in patients at low-intermediate pretest probability of infection, the stool test provides increased accuracy, with modest incremental costs.
Cost-Benefit Analysis↗
Absence of benefit of eradicating Helicobacter pylori in patients with nonulcer dyspepsia.
BACKGROUND: The relation between Helicobacter pylori infection and nonulcer dyspepsia is uncertain. We tested the hypothesis that curing the infection will relieve symptoms of dyspepsia. METHODS: We randomly assigned 170 H. pylori-infected patients with nonulcer dyspepsia to receive twice-daily treatment with 20 mg of omeprazole, 1000 mg of amoxicillin, and 500 mg of clarithromycin for 14 days and 167 such patients to receive identical-appearing placebos; all patients were then followed through regular visits for 12 months. Symptoms were scored on diary cards for seven days before each visit. A carbon-13 urea breath test was performed at base line and repeated at 1 and 12 months, and endoscopic biopsy was performed at 12 months to determine H. pylori status. Treatment was considered successful if the patient had only mild pain or discomfort or none at all. RESULTS: The rate of eradication of H. pylori infection was 90 percent in the active-treatment group and 2 percent in the placebo group at four to six weeks (P<0.001). At 12 months, there was no significant difference between groups in the rate of successful treatment (46 percent in the active-treatment group and 50 percent in the placebo group; relative likelihood of success with active treatment, 0.93; 95 percent confidence interval, 0.73 to 1.18; P=0.56). There was also no significant difference in the rate of successful treatment at 12 months between patients who were H. pylori-negative and those who were H. pylori-positive (48 percent vs. 49 percent). The rates of successful treatment were also similar when patients were analyzed according to the type of dyspepsia (ulcer-like, reflux-like, or dysmotility-like) and changes in the quality of life. There was no significant association between treatment success and histologic improvement in chronic gastritis at 12 months (P=0.68). CONCLUSIONS: We found no evidence that curing H. pylori infection in patients with nonulcer dyspepsia leads to relief of symptoms.
Adolescent↗
Effectiveness of Helicobacter pylori therapies in a clinical practice setting.
BACKGROUND: Whether eradication rates for Helicobacter pylori treatment regimens obtained in controlled clinical trials (efficacy) can also be obtained in clinical practice (effectiveness) is unknown because no such trials have been reported in the United States. OBJECTIVES: To determine the eradication rates of H pylori in a community practice setting and the effects of practice variation in the choice of treatment regimen on patient outcome (H pylori infection cure) and cost. METHODS: Between February 1 and December 30, 1996, 38 community-based gastroenterologists in the Portland, Ore, metropolitan area enrolled a total of 250 patients infected with H pylori, as determined by endoscopic or noninvasive methods. Various therapeutic regimens aimed at eradicating H pylori were used by the gastroenterologists, and a posttreatment urea breath test was used to determine H pylori infection cure. Compliance and incidental effects were also measured and decision analysis was used to estimate the cost of treatment. RESULTS: The regimens used varied considerably. Patients receiving a 2- or 3-times-a-day treatment regimen were significantly more compliant (P=.01) than those receiving a 4-times-a-day regimen. Proton pump inhibitor-based triple-therapy regimens were significantly more effective than all other treatment regimens combined (87% vs 70%; P = .001) in eradicating H pylori. These proton pump inhibitor-based triple-therapy regimens were also more cost-effective by decision analysis for a hypothetical cohort of patients with duodenal ulcer disease. CONCLUSIONS: The considerable variation in the choice of treatment regimens affects the clinical and economic outcomes of patients undergoing therapy for H pylori infection. Whether these data reflect the outcome in other communities is unknown but should be determined. It will be necessary to determine if the dissemination of these data results in a reduction of practice variation and improvement in clinical and economic outcomes of patients being treated for H pylori infection in clinical practice.
Anti-Bacterial Agents↗
Treatment of Helicobacter pylori.
Overwhelming evidence implicates Helicobacter pylori as a significant causative factor in many gastroduodenal diseases. Effective multidrug antimicrobial regimens are available for cure of the infection, so investigative efforts are focusing on cost-effectiveness and treatment outcome in various populations. Potential associations between H. pylori and nongastric disorders are being examined. Recognition that infection is largely acquired during childhood has emphasized the need to study pediatric issues. Posttreatment studies confirm the importance of the bacterium in pathogenesis and relapse of peptic ulcer disease. Antimicrobial resistance has a negative impact on cure of the infection and healing of gastroduodenal lesions. Methodology to evaluate H. pylori antimicrobial susceptibility has been standardized by the National Committee for Clinical Laboratory Standards, and minimum inhibitory concentration breakpoints to standardize resistance assays are being established. Surveillance of H. pylori antimicrobial resistance is underway in a Centers for Disease Control and Prevention multisite project in the United States.
Journal Article↗
Ten-day triple therapy with ranitidine bismuth citrate, amoxicillin, and clarithromycin in eradicating Helicobacter pylori.
OBJECTIVE: Fourteen-day therapy with ranitidine bismuth citrate, amoxicillin, and clarithromycin has been shown to have a high Helicobacter pylori eradication rate (> 90%) in U.S. trials. The aim of this study was to determine the H. pylori eradication rate of a ranitidine bismuth citrate-based triple regimen of shorter duration (10 days), which has been shown to be effective in Europe. METHODS: Dyspeptic patients who had a positive baseline 13C-urea breath test and either a positive antral rapid urease test or positive IgG serology were studied. Treatment consisted of ranitidine bismuth citrate 400 mg, clarithromycin 500 mg, and amoxicillin 1 g, all given b.i.d. for 10 days. Eradication was determined >4 wk after completion of therapy by the 13C-urea breath test (enrichment <2.4%). Results are expressed for intent-to-treat (all patients randomized even if they did not take the drug) and per-protocol (major protocol violators excluded) analyses. RESULTS: Seventy-seven patients with a mean age of 48 +/- 1.8 yr were studied. Forty-eight patients had eradication of H. pylori with this regimen (62%), 16 patients (21%) did not have eradication, and 13 patients (17%) did not return for breath testing. By intent-to-treat analysis the eradication rate was 62% (95% confidence intervals [CI], 51%, 73%) and by per-protocol analysis the eradication rate was 75% (95% CI, 63%, 85%). CONCLUSIONS: Ten-day, twice-daily therapy with ranitidine bismuth citrate, amoxicillin, and clarithromycin has an eradication rate that ranges from 62-75%. Fourteen-day therapy may be preferable because of higher eradication rates.
Amoxicillin↗
Plastic stents in the esophagus: is homemade really better?
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Constriction, Pathologic↗
Human tissue responses to metal stents.
Metal stents have become an important addition to therapeutic strategies available for incurable gastrointestinal malignancies. The responses of human tissues to the presence of metal stents are important for several reasons. The first is to understand the mechanism by which stents are anchored in the stenosis, as this will prevent migration of stents. The second is to develop new designs of stents that would be removable. The third reason is to prevent complications of stents, such as benign hypertrophy at the proximal and distal ends of the stent, and to understand the mechanism of serious complications, such as migration through the esophageal wall or aortoesophageal fistula. In this article, the authors discuss the state of the current knowledge in these three areas.
Animals↗
Cost savings in duodenal ulcer therapy through Helicobacter pylori eradication compared with conventional therapies: results of a randomized, double-blind, multicenter trial. Gastrointestinal Utilization Trial Study Group.
BACKGROUND: We hypothesized that treatment of duodenal ulcer disease with antibiotic therapy directed toward Helicobacter pylori infection is more cost-effective than therapy with antisecretory agents. METHODS: A randomized, double-blind, multicenter clinical trial of adult patients with active duodenal ulcer and H. pylori infection was conducted. Patients were randomized to receive 500 mg of clarithromycin 3 times a day plus 40 mg of omeprazole daily for 14 days followed by 20 mg of omeprazole daily for an additional 14 days (group 1), 20 mg of omeprazole daily for 28 days (group 2), or 150 mg of ranitidine hydrochloride twice a day for 28 days (group 3). The use of ulcer-related health care resources was documented during monthly interviews for 1 year after the initial therapy. Clinical success was evaluated 4 to 6 weeks and 1 year after the end of therapy. RESULTS: Of the 819 patients enrolled, 727 completed the study. Group 1 included 243 patients; group 2, 248 patients; and group 3, 236 patients. Patients in group 1 used fewer ulcer-related health care resources during the 1 year after therapy compared with groups 2 and 3 (comparisons are given as group 1 vs group 2 and group 1 vs group 3, respectively): the number of endoscopies performed, 28 vs 76 (P<.001) and vs 71 (P<.001); patients receiving drugs to treat an ulcer, 118 vs 180 (P<.001) and vs 168 (P<.001); clinic visits, 83 vs 135 (P=.05) and vs 161 (P<.001); hospitalizations, 0 vs 5 (P=.045) and vs 6 (P=.02); and length of hospital stay, 0 vs 24 days (P=.04) and vs 37 (P=.04). When ulcer-related costs were defined as the outcome variable in a multivariate linear regression analysis, therapy was determined to have a significant influence on costs (group 1 vs group 2, P<.001; group 1 vs group 3, P=.008). Clinical success rates at the end of the study and cure of H. pylori infection were significantly greater in group 1 compared with groups 2 and 3 (P<.001). Therapy with clarithromycin plus omeprazole provided savings of $1.94 and $2.96 (compared with therapy with omeprazole and with ranitidine hydrochloride, respectively) per dollar spent within the first year after therapy. This incremental cost-benefit translates to savings of $547 or $835 per patient in group 1 (compared with patients in group 2 or group 3, respectively) during the first year after therapy. CONCLUSIONS: Combination therapy with clarithromycin and omeprazole resulted in significantly fewer uses of ulcer-related health care resources than conventional antisecretory therapy during a 1-year follow-up and significant savings in associated costs during the same period. Patients who received clarithromycin plus omeprazole also showed a significantly improved clinical outcome compared with patients who received only omeprazole or ranitidine.
Adult↗
Treatment of Helicobacter pylori infection.
Helicobacter pylori infection has been shown to be the principal cause of peptic ulcer disease and has been associated with MALT lymphoma and gastric cancer. Eradication of H. pylori has been shown to change the natural history of peptic ulcer disease by preventing relapse and to reduce health care expenditures when compared with traditional therapy. Two-drug regimens have been superceded by three-drug regimens because they are more effective in eradication. Therapies with the highest efficacy are cost-effective because failed eradication is associated with high costs.
Antacids↗